Multi-center Study of Residual Neuromuscular Block Incidence in the Post-anesthesia Care Unit

Overview

Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is a source of complications, mainly respiratory. The incidence is variable due to multiple factors. In Spain the incidence is unknown.

The investigators hypothesize that a number of patients in the postanesthesia care unit (PACU) present with RNMB after general anesthesia using intermediate action neuromuscular block agents (NMBA).

The main objective is to know the incidence of RNMB in Spanish hospitals. Secondary objectives are to observe the possible relationship with other pre- and intraoperative factors.

Full Title of Study: “Incidence of Residual Neuromuscular Block in Adult Patients in the Postanesthesia Care Unit. An Observational Cross-sectional Study of a Multicenter Cohort. The Residual Curarization in Spain Study (ReCuSS).”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: July 2014

Detailed Description

Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is a source of complications, mainly respiratory. This includes recovery delay or hospital discharge delays, respiratory insufficiency or infections, unforeseen ICU admissions, and prolonged ICU stays.

The incidence is variable due to multiple factors. Age, gender, surgery, NMBA type and doses, temperature, medications, etc.

In several studies it has been found and incidence between 6-80%. Few studies have been focused in evaluating the incidence in the whole country, as representing a global anesthesia practice. In Spain the incidence is unknown.

The investigators hypothesize that a number of patients in the postanesthesia care unit (PACU) present with RNMB after general anesthesia using intermediate action NMBA.

The main objective is to know the incidence of RNMB in Spanish hospitals, by means of an observational cross-sectional multicenter study .

Secondary objectives are to observe the possible relationship with other pre- and intraoperative factors.

Interventions

  • Device: Accelerometry
    • Application of TOF stimulus (40 mA, three to four times) and recording TOFr in the PACU

Arms, Groups and Cohorts

  • General anesthesia
    • Evaluation of RNMB. Application of accelerometry to patients after general anesthesia receiving at least one intermediate action nondepolarizing neuromuscular blocking agent dose

Clinical Trial Outcome Measures

Primary Measures

  • Residual neuromuscular block incidence (TOFr<0.9) measured by accelerometry in the PACU
    • Time Frame: Upon arrival to the PACU. Single evaluation.
    • Patients operated on under general anesthesia including intermediate duration NMBA were evaluated by means of an accelerometer in the PACU immediately upon arrival. Train-of-four ratio (TOFr) is evaluated. The evaluator does’nt know the patient-related information, including intraoperative management.

Secondary Measures

  • Respiratory or airway postoperative complications in the PACU
    • Time Frame: During PACU stay, an expected average of 4 hours
    • Evaluation of respiratory complications or events in the PACU (asking the anesthesiologist in charge or PACU medical record) to discharge to the ward.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients >18 years-old
  • General anesthesia with non-depolarizing NMBA
  • Transferred extubated on spontaneous ventilation to the PACU

Exclusion Criteria

  • American Society of Anesthesiologists physical status IV-V
  • emergency and cardiac surgery
  • patients unable to respond adequately at the moment of pre- or postoperative evaluation (psychiatric diseases, excessive somnolence, agitation, etc.)
  • noncompensated diabetes mellitus or diabetic neuropathy
  • symptomatic severe hypothyroidism (or untreated), or scheduled for total thyroidectomy
  • chronic or acute renal insufficiency
  • severe hepatopathy (Child-Pugh B, C)
  • intraoperative blood transfusion >3 blood units
  • intraoperative maintained arterial hypotension
  • arrival to the PACU intubated or with instrumented airway (including surgical)
  • pre- or perioperative drugs intake affecting the neuromuscular transmission
  • neuromuscular diseases affecting the physiology of the neuromuscular system

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Valencia
  • Collaborator
    • Valencia University General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Carlos Luis Errando, MD, PhD, staff anesthesiologist – Valencia University General Hospital
  • Overall Official(s)
    • Carlos L Errando, MD, PhD, Principal Investigator, Servicio de Anestesiologia. Consorcio Hospital General Universitario de Valencia
    • Ignacio Garutti, MD, PhD, Principal Investigator, Servicio de Anestesiologia. Hospital Universitario Gregorio MaraƱon

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